Who is the manufacturer of Electrosurgical Generator?

New Deantronics Taiwan , Ltd. filed the 510(k) submission for Electrosurgical Generator (K201221).

What is the FDA product code for Electrosurgical Generator?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Electrosurgical Generator?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Electrosurgical Generator?

Force FX™ electrosurgical generators (K143161).

Who can help prepare an FDA 510(k) submission like Electrosurgical Generator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Electrosurgical Generator

K201221 · New Deantronics Taiwan , Ltd. · GEI · Sep 28, 2020 · General, Plastic Surgery

Device Facts

Record ID	K201221
Device Name	Electrosurgical Generator
Applicant	New Deantronics Taiwan , Ltd.
Product Code	GEI · General, Plastic Surgery
Decision Date	Sep 28, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.

Device Story

Solid-state electrosurgical generator; supplies radiofrequency (RF) electrical energy to compatible surgical instruments. Input: mains power; user-selected modes (Monopolar CUT: Pure, Blend 1, Blend 2; Monopolar COAG: Pin Point, Spray; Bipolar: Standard). Operation: activated via hand or foot switch; energy concentration at instrument tip produces heat for tissue cutting/coagulation. Features Return Electrode Contact Quality Monitor (CQM) to alert user of inadequate neutral electrode contact. Used in clinical/surgical settings by surgeons. Output: high-frequency RF energy. Benefits: provides controlled tissue cutting and hemostasis during surgery.

Clinical Evidence

Bench testing only. No clinical data provided. Device demonstrated compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (high-frequency surgical equipment) standards, as well as the FDA guidance for electrosurgical devices.

Technological Characteristics

Solid-state RF generator; dimensions 37cm x 29cm x 17cm; weight 5kg. Energy source: mains power. Output: isolated, CF type. Monopolar and bipolar modes. Features Return Electrode Contact Quality Monitor (CQM). Software lifecycle per IEC 62304. Standards: IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, IEC 60601-2-2:2017.

Indications for Use

Indicated for use by surgeons during surgical procedures requiring electrosurgical cutting and coagulation, utilizing monopolar and bipolar technology.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

Force FX™ electrosurgical generators (K143161)

Related Devices

K100390 — SURGIMAX/ SURGIMAX PLUS · Elliquence, LLC · Aug 25, 2010
K172757 — Valleylab FX8 Electrosurgical Platform · Covidien, LLC · Nov 2, 2017
K162656 — ESU-1 Electrosurgical Generator · Tva Medical, Inc. · Nov 10, 2016
K171869 — Sutter CURIS RF Generator · Sutter Medizintechnik GmbH · Feb 23, 2018
K210488 — Ultrasonic Surgical & Electrosurgical Generator · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Oct 25, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 28, 2020 New Deantronics Taiwan Ltd. % Craig Coombs President Coombs Medical Device Consulting, Inc. 1100 Pacific Marina, Suite 806 Alameda. California 94501 Re: K201221 Trade/Device Name: Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 8, 2020 Received: September 9, 2020 Dear Craig Coombs: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K201221 Device Name Electrosurgical Generator #### Indications for Use (Describe) The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and there is a blue circle with a red dot in the middle. The word "DEANTRONICS" is in blue and is to the right of the circle. K201221 # Section 5: 510(k) Summary ## A. Device Information: | Category | Comments | |------------------------------------------|------------------------------------------| | Sponsor: | New Deantronics Taiwan Ltd. | | | 12F., No.51, Sec. 4, Zhongyang Rd., | | | Tucheng District | | | New Taipei City 236, | | | Taiwan. | | | Tel: (886) 2-2268-1726 | | | Fax: (886) 2-2268-3800 | | | Sponsor Contact: Ms. Jane Liu, President | | | Email: jane@newdean.com.tw | | Correspondent Contact Information: | Mr. Craig Coombs | | | President | | | Coombs Medical Device Consulting | | | 1100 Pacific Marina, Suite 806 | | | Alameda, CA 94501 | | | Tel: 510-995-8499 | | | Email: CraigJCoombs@gmail.com | | Device Common Name: | Electrosurgical Generator | | Device Classification Number: | 21 CFR 878.4400 | | Device Classification & Product Code: | Class II, GEI | | Device Proprietary Name: | Electrosurgical Generator | ### Predicate Device Information: | Predicate Device: | Force FX™ electrosurgical generators | |----------------------------------------------------|-------------------------------------------------------------------------------------| | Predicate Device Manufacturer: | Covidien (formerly Valleylab, Inc.) | | Predicate Device Common Name: | Electrosurgical Generator | | Predicate Device Premarket Notification #: | K143161 | | Predicate Device Classification: | 21 CFR 878.4400 Electrosurgical, Cutting & Coagulation Device and Accessories | | Predicate Device Classification & Product Code: | Class 2, GEI | ### B. Date Summary Prepared 4 May 2020 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for New Deantronics. The logo has the word "NEW" stacked on top of a blue circle with a red dot in the middle. To the right of the circle is the word "DEANTRONICS" in blue. The logo is simple and professional. ### C. Description of Device The application device, the Electrosurgical Generator, is a solid state generator designed to supply radiofrequency electrical energy for general electrosurgical purposes, with physical dimensions around 37cm (L) x 29cm (W) x 17cm (H) and 5kg unit weight. The Electrosurgical Generator supplies high frequency electrosurgical power from low power (<30W), medium power (Cut: 30~100W, Coag: 30~70W), to high power (Cut >100W, Coag>70W). The Electrosurgical Generator outputs high frequency energy in the following modes: - 1. Monopolar CUT: Pure Blend 1 Blend 2 - 2. Monopolar COAG: Pin Point Spray - 3. Bipolar: Standard The Electrosurgical Generator can be activated via a hand switch or a foot switch. The Electrosurgical Generator has a Return Electrode Contact Quality Monitor to alert the user when inadequate contact is being made with the Return (aka Neutral) Electrode. The Electrosurgical Generator is mains powered. #### D. Indications for Use The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. {5}------------------------------------------------ ## E. Comparison to Predicate Device | Feature | Application Device: Electrosurgical Generator (Model: ES300, K201221) | Predicate: Covidien Force FXTM Electrosurgical Generator (K143161) | Pertinence of Feature to Consideration of Substantial Equivalence | |---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. | The Force FX™ Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating) and coagulating (hemostasis). | Identical, except specific examples of clinical techniques were dropped as unnecessary. | | FDA Product Code | GEI | GEI | Identical | | Operating Principle | The Electrosurgical Generator is a radio- frequency (RF) electrosurgical generator that delivers energy to compatible surgical instruments. The concentration of energy at the tip of the instrument in conjunction with tissue characteristics produces heat. The heating of tissue provides the desired surgical effect (cutting, coagulation). Variations in the waveform result in the different surgical effects achieved by different modes. | The Force FXTM is a radio- frequency (RF) electrosurgical generator that delivers energy to compatible surgical instruments. The concentration of energy at the tip of the instrument in conjunction with tissue characteristics produces heat. The heating of tissue provides the desired surgical effect (cutting, coagulation). Variations in the waveform result in the different surgical effects achieved by different modes. | Identical | | Input Power | 100 - 240 V | 100 - 240 V | Identical | | Output configuration | Isolated | Isolated | Identical | | Type | CF | CF | Identical | | Working theories | | | | | Monopolar | ESU generator connects its electrosurgical electrode accessories and a neutral pad to form a cyclic circuit, the HF current generated from the generator and through the accessory to achieve CUT or COAG, and then return to generator by the neutral pad. | ESU generator connects its electrosurgical accessories and a neutral ESU pad to form a cyclic circuit, the HF current generated from the generator and through the accessory to achieve CUT or COAG, and then return to generator by the neutral pad. | Identical | | Monopolar | ESU generator connects its electrosurgical electrode accessories and a neutral pad to form a cyclic circuit, the HF current generated from the generator and through the accessory to achieve CUT or COAG, and then return to generator by the neutral pad. | ESU generator connects its electrosurgical accessories and a neutral ESU pad to form a cyclic circuit, the HF current generated from the generator and through the accessory to achieve CUT or COAG, and then return to generator by the neutral pad. | Identical | | | | | | | Feature | Application Device: Electrosurgical Generator (Model: ES300,K201221) | Predicate: Covidien Force FX™ Electrosurgical Generator (K143161) | Pertinence of Feature to Consideration of Substantial Equivalence | | Bipolar | HF current generated from the generator and the cyclic circuit formed between the two tips of the bipolar forceps, the HF power through the two tips to work on patient obtaining COAG, no need extra ESU pad. | HF current generated from the generator and the cyclic circuit formed between the two tips of the bipolar forceps, the HF power through the two tips to work on patient obtaining COAG, no need extra ESU pad. | Identical | | Physical Specification | | | | | Appearance | Image: Electrosurgical Generator (Model: ES300,K201221) | Image: Covidien Force FX Electrosurgical Generator (K143161) | Different, but they do not raise new issues of safety or effectiveness. | | Dimensions | 29.5 cm x 37.6 cm x 17.8 cm | 35.6 cm x 35.6 cm x 11.1 cm | | | and weight | Weight: < 11.68 lb (< 5.3 kg) | Weight: < 18 lb (< 8.2 kg) | | | Display | One 7.0" high digital display | Eight digital seven-segment displays: 0.75″ high each | | | Energy | HF energy | HF energy | Identical | | Performance Specification | | | | | | Monopolar CUT: Pure Blend 1 Blend 2 | Monopolar CUT: Low cut Pure cut Blend | | | Output mode | Monopolar COAG: Pin point Spray | Monopolar COAG: Low (Desiccate) Med (Fulgurate) High (Spray) | Nonclinical differences. Both the application device and predicated ones have monopolar CUT, monopolar COAG and BIPOLAR. Both of them are sinusoid | | | BIPOLAR: Standard | BIPOLAR: Low (Precise) Med (Standard) Macro | as well as a similar output power under the same output mode, accordingly with the similar crest factor. The small differences have no influence on safety and performance. | | | | | | | Feature | Application Device: Electrosurgical Generator (Model: ES300, K201221) | Predicate: Covidien Force FX™ Electrosurgical Generator (K143161) | Pertinence of Feature to Consideration of Substantial Equivalence | | Waveforms - Cut Waveforms - Coag Waveforms - Bipolar | Pure Cut Blend 1 Blend 2 | Low Pure Blend | The frequencies are above 200 kHz, belong to High frequency range based on IEC60601-2-2 requirement; The related waveforms of the ES300 and Force FX have similar shapes, slight differences exist because of respective component parameters, which have no influence in the actual application process. | | | Spray Coagulation Pin point Coagulation | Desiccate Fulgurate Spray | | | | Bipolar Coagulation | Low(precise) Med(standard) Macro | | | Special Functions | | | | | Pad Control System (PCS) | The Return Electrode Contact Quality Monitor (CQM) will measure the resistance, if the resistance was beyond the range of defined by an upper and lower limit, the alarm system will be activated. | The Return Electrode Contact Quality Monitor (REM) will measure the resistance, if the resistance was beyond the range of defined by an upper and lower limit, the alarm system will be activated. | Identical | | Operating | Only one output device to be activated at any given time, except for monopolar coagulation | Only one output device to be activated at any given time, except for monopolar coagulation | Identical | | Activation Tones | Yes | Yes | The frequencies are different, but it does not affect device safety and performance | | Alarm Tone | Yes, Multiple | Yes, Single | The frequencies and number of tones are different, but this does not affect device safety and performance | | Others | | | | | Principal Operator | Surgeon | Surgeon | Identical | | Feature | Application Device: Electrosurgical Generator (Model: ES300, K201221) | Predicate: Covidien Force FX™ Electrosurgical Generator (K143161) | Pertinence of Feature to Consideration of Substantial Equivalence | | Performance/ Safety Testing in accordance with | IEC 60601-1: 2005+A1:2012 IEC 60601-1-2:2014 IEC 60601-2-2:2017 Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020) | IEC 60601-1:2005 IEC 60601-1-2:2007 IEC 60601-2-2:2009 | Both devices were developed with the most up-to-date IEC 60601 standards at the time. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and there is a blue circle with a red dot in the middle. The word "DEANTRONICS" is in blue and is to the right of the circle. Electrosurgical Generator Traditional Premarket Notification {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, with a blue circle and red dot next to it. The word "DEANTRONICS" is in blue and to the right of the circle. Electrosurgical Generator Traditional Premarket Notification {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and the "N" is slightly larger than the other letters. To the right of "NEW" is a blue circle with a red dot in the center. To the right of the circle is the word "DEANTRONICS" in blue. Electrosurgical Generator Traditional Premarket Notification ### F. Summary of Supporting Data The application Electrosurgical Generator was tested and found to be in compliance with the following standards: | Standards Body & # | Standard Name | Standard Version | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. | 2005 + AMD1:2012 | | IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and tests. | 2014 | | IEC 60601-2-2 | Medical electrical equipment –Part 2-2: Particular requirements for the safety of high frequency surgical equipment. | 2017 | | IEC 62304 | Medical device software — Software life cycle processes | 2006+ AMD 1:2015 | | ISTA 3A | International Safe Transit Association Procedure 3A. | 2008 | In addition, the Electrosurgical Generator was fully tested and in compliance with the FDA guideline Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020). #### G. Conclusion After comparing the Indications for Use, technology and design of the Electrosurgical Generator, along with all electrical safety (including IEC 60601-1: 2005 + AM1:2012; IEC 60601-1-2: 2014; IEC 60601-2-2: 2017) and performance testing, in accordance with the FDA's guidelines and FDA-recognized consensus standards for electrical safety, New Deantronics concludes that the Electrosurgical Generator is substantially equivalent to the predicate Covidien Force FX Electrosurgical Generator (K143161).